510(k) · Cleared
Recalled · Class I · 2019Enflow IV Fluid Warmer Insulated Strap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Signs, Inc., A GE Healthcare Company · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Jun 14, 2013 as substantially equivalent to K121775 (Vital Signs, Inc., A GE Healthcare Company, 2012) after a 78-day review. Its family tree reaches back 6 generations to 1977. 3 of the 9 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jun 14, 2013
- Review
- 78 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K770232 (1977). 8 ancestors in all. No later device cites it as a predicate yet. 3 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 5 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 4 generations backK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- 3 generations backK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- 2 generations backK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- 1 generation backK121775 Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company · 2012
- This deviceK130867 Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −5 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −4 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| −3 | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | Class I |
| −2 | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| −1 | K121775 | Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow Controller | Vital Signs, Inc., A GE Healthcare Company | 2012 | — |
| 0 (this device) | K130867 | Enflow IV Fluid Warmer Insulated Strap | Vital Signs, Inc., A GE Healthcare Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LGZ device
- #1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121775 | Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerSummary page 1…Usual Name: | enFlow, Insulated strap, i-strap Classification Names: | Warmer, Thermal, Infusion fluid Product Code: | LGZ BSB - 21 CFR 864.9205 Predicate Devicels): | K121775, enFlow IV Fluid Warmer Strap 33 GE Healthcare , 510(k) Premarket Notification Submission Device Description:… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2019 | Class I | Z-1385-2019 | Device Design | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
| Mar 13, 2019 | Class I | Z-1386-2019 | Device Design | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120Enginivity, LLC · 2006 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LGZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGZ
546in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGZ
376in 2025
MAUDE reports naming product code LGZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 4 | 99 | 0 | 10 |
| 2009 | 2 | — | 1 | 12 |
| 2010 | 2 | — | 1 | 43 |
| 2011 | 3 | 77 | 8 | 54 |
| 2012 | 7 | 162 | 0 | 52 |
| 2013 | 5 | 143 | 0 | 16 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 2 | — | 1 | 34 |
| 2016 | 2 | — | 1 | 15 |
| 2017 | 2 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 94 |
| 2019 | 3 | 209 | 0 | 340 |
| 2020 | 0 | — | 0 | 1,221 |
| 2021 | 0 | — | 0 | 885 |
| 2022 | 3 | 546 | 0 | 1,548 |
| 2023 | 1 | — | 0 | 1,033 |
| 2024 | 1 | — | 0 | 862 |
| 2025 | 2 | — | 0 | 376 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130867: Enflow IV Fluid Warmer Insulated Strap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026